Completed

NCT Number: NCT01807260

Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

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Key information

Conditions

Pediatric Urinary Lithiasis

Age range

12 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Erciyes University Medical Faculty,

Kayseri, Talas, 38280, Turkey (Türkiye)

About this study

Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patients with pediatric urinary lithiasis.

Exclusion criteria

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Treatment and study plan

Shock Wave Lithotripsy

Procedure

All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.

Primary outcomes

Stone burden on plain X-ray.

Time frame: Three months.

The stone burden was defined as the stone area that was calculated by multiplying the largest length(cm)and width (cm)of the individual stones measured from the abdominal plain X-ray. To detect fragmentation of the stone and necessity of re-treatment a plain film were used during control. Stone clearance was assessed at three months. Stone-free state was defined as the absence of stone fragments on a good quality plain X-ray. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.

Other outcomes

Degree and presence of hydronephrosis.

Time frame: Three months

To detect obstruction in the system, ultrasonography was used during control.
Stone burden on spiral computed tomography

Time frame: Three months

In case of non-opaque Stones, stone borden was evalusted with spinal computed tomography. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Mar 8, 2013
Registry last updated: Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.